Tetravalent influenza virus subunit vaccine and preparation method thereof

A subunit vaccine and influenza virus technology, applied in the field of quadrivalent influenza virus subunit vaccine and its preparation, can solve problems such as the loss of active ingredients, shorten the storage period of vaccines, and reduce the level of antibodies, so as to prolong the storage period, reduce the content, Effects of Elevated Antibody Levels

Active Publication Date: 2020-07-17
ZHONGYI ANKE BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Such a result may cause that during the storage of the vaccine, excess free formaldehyde aldehyde groups continue to act on the antigen of the virus, causing the antigen to gradually degrade under the action of the aldehyde group, so that the active ingredients in the vaccine continue to pass away, which not only shortens the time of vaccine production. The shelf life of the vaccine also reduces the production of antibody levels after vaccine immunization

Method used

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  • Tetravalent influenza virus subunit vaccine and preparation method thereof
  • Tetravalent influenza virus subunit vaccine and preparation method thereof
  • Tetravalent influenza virus subunit vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] One, A 1 (H1N1) type influenza virus subunit vaccine monovalent stock solution production method, comprises the following steps successively:

[0035] (1) Virus inoculation: Inoculate the A1 (H1N1) type influenza virus working seeds in the allantoic cavity of 10-day-old healthy chicken embryos;

[0036] (2) Virus propagation and cultivation: transfer the inoculated chicken embryos to a 34° C. incubator for 48 hours to propagate the influenza virus;

[0037] (3) Harvesting of allantoic fluid: screen live chicken embryos, place the embryos at 2°C for 16 hours, and harvest the allantoic fluid;

[0038] (4) Clarification: remove most of the impurities such as chicken embryo red blood cells by centrifugation;

[0039] (5) Inactivation: Add carboxymethyl dextran solution with a concentration of 3g / 100mL to the monovalent virus harvest solution, wherein the volume ratio of the added amount of carboxymethyl dextran solution to the monovalent virus harvest solution is 1:0.3 , ...

Embodiment 2

[0067] Specifically with embodiment 1, the difference is:

[0068] One, in the production method of monovalent stock solution of A1 (H1N1) influenza virus subunit vaccine:

[0069] Step (3) is: screening live chicken embryos, and harvesting allantoic fluid after placing cold embryos at 5°C for 16 hours;

[0070] Step (5) is: add carboxymethyl dextran solution with a concentration of 1g / 100mL to the monovalent virus harvest solution, wherein the volume ratio of the added amount of carboxymethyl dextran solution to the monovalent virus harvest solution is 1:0.5 , the degree of substitution of carboxymethyl dextran is 0.5, then add formaldehyde with a final concentration of 100mg / ml, and inactivate at 5°C for 35 hours;

[0071] In step (7), the concentration of the splitting agent nonoxynol-9 is 0.01%.

[0072] Two, in the production method of monovalent stock solution of influenza virus subunit vaccine of type A 3 (H3N2):

[0073] Step (3) is: screening live chicken embryos, ...

Embodiment 3

[0081] Specifically with embodiment 1, the difference is:

[0082] One, in the production method of monovalent stock solution of A1 (H1N1) influenza virus subunit vaccine:

[0083] Step (3) is: screening live chicken embryos, and harvesting the allantoic fluid after placing the embryos at 8°C for 16 hours;

[0084] Step (5) is: add carboxymethyl dextran solution with a concentration of 5g / 100mL to the monovalent virus harvest solution, wherein the volume ratio of the added amount of carboxymethyl dextran solution to the monovalent virus harvest solution is 1:0.7 , the degree of substitution of carboxymethyl dextran is 0.7, then add formaldehyde with a final concentration of 150mg / ml, and inactivate at 8°C for 35 hours;

[0085] In step (7), the concentration of the splitting agent nonoxynol-9 is 2%.

[0086] Two, in the production method of monovalent stock solution of influenza virus subunit vaccine of type A 3 (H3N2):

[0087] Step (3) is: screening live chicken embryos, ...

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Abstract

The invention belongs to the technical field of biology, and particularly relates to a tetravalent influenza virus subunit vaccine and a preparation method thereof. Each dose of the tetravalent influenza virus subunit vaccine contains H1N1, H3N2 and two types of B; and the tetravalent influenza virus subunit vaccine is prepared by virus inoculation, virus multiplication culture, allantoic fluid harvesting, clarification, inactivation, ultrafiltration concentration, cracking and ultracentrifugal purification, mixing, filtration sterilization, split charging and packaging, wherein the inactivation process comprises the following steps: firstly, adding a carboxymethyl glucan solution into monovalent virus harvesting liquid, and then adding formaldehyde for inactivation. According to the method disclosed by the invention, the content of free formaldehyde in the prepared tetravalent influenza virus subunit vaccine is reduced, the storage life of the vaccine is prolonged, and the antibody level after vaccine immunization is increased.

Description

technical field [0001] The invention belongs to the field of biotechnology, in particular to a quadrivalent influenza virus subunit vaccine and a preparation method thereof. Background technique [0002] Influenza is caused by influenza virus, which can cause large-scale epidemics of acute respiratory diseases transmitted by humans and animals. Influenza viruses are divided into three types: A, B, and C. Among them, type A has the strongest pathogenicity and can infect animals and humans and cause epidemics or even worldwide pandemics; type B is slightly less pathogenic and can cause local epidemics. Influenza viruses often undergo antigenic drift and antigenic shift to evade the defenses of the body's immune system, which is also the cause of the pandemic. Influenza viruses are highly contagious and spread through the air through droplets. After a short incubation period, high fever and chills develop rapidly, and the body temperature can reach as high as 40°C within 1-2...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/295A61K39/145A61P31/16
CPCA61K39/12A61K2039/5252A61K2039/70A61P31/16C12N2760/16134C12N2760/16163C12N2760/16234C12N2760/16263
Inventor 高辉阮承迈
Owner ZHONGYI ANKE BIOTECH CO LTD
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